New

IVD Regulatory Support Specialist

YOH Services LLC
401(k), employee discount
United States, California, Hercules
May 14, 2025
IVD Regulatory Support Specialist Category: Manufacturing & Production Employment Type: Contract Reference: BH-385326 IVD Regulatory Support Specialist needed for a contract with Yoh Scientific's client located in Hercules, CA. This position is for a molecular diagnostics manufacturer and the team is looking for candidates with experience in IVD medical device industry (required). Schedule: Hybrid after 30 days M and Tuesdays on site, the third day candidate's choice. 8:00 to 4:30 however we are flexible. Responsibilities Provide regulatory support for IVD products with multiple product groups with clinical diagnostics. Assembles low to medium complexity regulatory submissions to support worldwide product registration. IVDR Technical file maintenance and monitoring of change requests. Process improvements for SOPs related to full transition to IVDR. Basic analytical, communication, problem solving, and critical thinking skills to meet daily job responsibilities. Interface daily with desktop publishers, technical writers and regulatory specialists. Work collaboratively with Marketing, R & D, QA, Planning and Manufacturing teams. Strong prioritization skills, flexibility and ability to handle multiple projects simultaneously while meeting deadlines Ability to communicate effectively with employees across multiple departments Highly organized and detail oriented. Good time management. Technical aptitude for understanding IVD product features Understanding of databases and electronic systems. Qualifications Education: BS in Biology or other scientific field Work Experience: 0-2 years' experience in IVD regulatory affairs. Proficient use of MS Office applications (e.g., Excel, Word, PowerPoint, Teams) Laboratory research experience in an IVD medical device regulated environment is strongly preferred. Understanding scientific reports, risk management, Quality Systems Opportunity is Calling, Apply Now! Contract: 12-month contract with potential for extension and/or conversion Salary: $40 per hour, W2. Recruiter: Ery Baniqued What's In It For You? We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you. Medical, Dental & Vision Benefits 401K Retirement Saving Plan Life & Disability Insurance Direct Deposit & weekly ePayroll Employee Discount Programs Referral Bonus Programs Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here! Estimated Min Rate: $40.00 Estimated Max Rate: $40.00 Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process. For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship, potentially resulting in the withdrawal of a conditional offer of employment.